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Trial record 1 of 1 for:    NCT04326023
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Myelodysplastic Syndrome and Acute Myeloid Leukemia Related to PARP Inhibitors (MyeloRIB)

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ClinicalTrials.gov Identifier: NCT04326023
Recruitment Status : Completed
First Posted : March 30, 2020
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:

Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but life-threatening adverse events such as myelodysplastic syndrome (MDS) and/or acute myeloid leukaemia (AML). Today, data about MDS/AML are scarce.

The objective was to investigate reports of MDS/AML adverse events related to PARPi, including olaparib, rucaparib, niraparib, talazoparib and veliparib using the World Health Organization (WHO) and the French pharmacovigilance databases.


Condition or disease Intervention/treatment
Cancer Drug: PARP Inhibitors

Detailed Description:
Here, investigators use the World Health Organization (WHO) and the French database of individual safety case reports, to identify cases of MDS/AML related to PARPi.

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Study Type : Observational
Actual Enrollment : 178 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Myelodysplastic Syndrome and Acute Myeloid Leukemia Related to PARP Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the WHO and the French Pharmacovigilance Databases (MyeloRIB)
Actual Study Start Date : February 9, 2020
Actual Primary Completion Date : March 18, 2020
Actual Study Completion Date : May 3, 2020



Intervention Details:
  • Drug: PARP Inhibitors
    olaparib, rucaparib, niraparib, talazoparib, veliparib


Primary Outcome Measures :
  1. MDS/AML reports related to PARPi (from WHO database). [ Time Frame: From inception to May 3, 2020 ]
    Identification of the MDS and/or AML adverse event related to PARP inhibitors reported in the World Health Organization (WHO) database of individual safety case reports.

  2. MDS/AML reports related to PARPi (from French database). [ Time Frame: From inception to May 1, 2021 ]
    Identification of the MDS and/or AML adverse event related to PARP inhibitors reported in the French pharmacovigilance database of individual safety case reports. The aim is to describe clinical features of these rare adverse events, including bone marrow analyzes, cytogenetic and molecular abnormalities, blasts immunophenotyping anonymously reported in this database.


Secondary Outcome Measures :
  1. Description of the median time to onset since first PARPi exposure. [ Time Frame: From inception to May 3, 2020 ]
  2. Description of the fatality rate. [ Time Frame: From inception to May 3, 2020 ]
  3. Description of patients who experienced co-reported adverse events. [ Time Frame: From inception to May 3, 2020 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Cancer patients treated with PARPi and experiencing MDS/AML.
Criteria

Inclusion Criteria:

  • Case reported in the World Health Organization (WHO, also called VigiBase) or French database of individual safety case reports at the time of the extraction,
  • Patients treated with at least 1 PARPi (with ATC classification system): olaparib (ATC L01XX46), niraparib (ATC L01XX54), rucaparib (ATC L01XX55), talazoparib (ATC L01XX60), veliparib (none).

Exclusion Criteria:

  • Chronology not compatible between the PARPi and adverse event (MDS/AML)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04326023


Locations
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France
Alexandre Joachim
Caen, Basse Normandie, France, 14000
Sponsors and Collaborators
University Hospital, Caen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT04326023    
Other Study ID Numbers: Pharmaco 20200317
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Leukemia
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents